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SERENACE 500MCG CAPSULES

Active substance(s): HALOPERIDOL / HALOPERIDOL / HALOPERIDOL

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SERENACE 500 microgram CAPSULES
Haloperidol
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Read all of this leaflet carefully before you start taking
this medicine.
s +EEP THIS LEAFLET9OU MAY NEED TO READ IT AGAIN
s )F YOU HAVE ANY FURTHER QUESTIONS ASK YOUR DOCTOR OR
pharmacist.
s 4HIS MEDICINE HAS BEEN PRESCRIBED FOR YOU $O NOT
PASS IT ON TO OTHERS )T MAY HARM THEM EVEN IF THEIR
SYMPTOMS ARE THE SAME AS YOURS
s )F ANY OF THE SIDE EFFECTS GET SERIOUS OR IF YOU NOTICE
ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET PLEASE TELL
YOUR DOCTOR OR PHARMACIST
IN THIS LEAFLET:

25 March 2014

1. What Serenace is and what it is used for
2. Before you take Serenace
3. How to take Serenace
4. Possible side effects
5. How to store Serenace
6. Further information

1

Version:

2

3ERENACE #APSULES CONTAIN HALOPERIDOL WHICH BELONGS TO
A GROUP OF DRUGS KNOWN AS ANTIPSYCHOTICS
Serenace Capsules are used to treat:
s SCHIZOPHRENIA AND OTHER SIMILAR MENTAL DISORDERS
SUCH AS MANIA FEELING ELATED OR OVER EXCITED WHICH
CAUSES UNUSUAL BEHAVIOUR AND PARANOIA VIOLENT OR
DANGEROUS IMPULSIVE BEHAVIOUR
s AGGRESSION OVERACTIVITY AND SELF MUTILATION IN
PATIENTS WHO ARE MENTALLY ILL AND ARE LIKELY TO BEHAVE
DANGEROUSLY
s 4OURETTES SYNDROME TICS REPEATED AND LARGELY
INVOLUNTARY MOVEMENTS
s RESTLESSNESS AND AGITATION IN THE ELDERLY
s NAUSEA AND VOMITING
s WITH OTHER THERAPY THE SHORT TERM MANAGEMENT OF
ANXIETY
s BEHAVIOURAL DISORDERS IN CHILDREN ESPECIALLY THOSE
ASSOCIATED WITH HYPERACTIVITY AND AGGRESSION

231-30-01046-F LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK
2

BEFORE YOU TAKE SERENACE

DO NOT take Serenace and talk to your doctor if you:
s ARE ALLERGIC HYPERSENSITIVE TO HALOPERIDOL OR ANY OF
the other ingredients of this medicine
s ARE BREAST FEEDING
s HAVE BEEN TOLD BY YOUR DOCTOR THAT YOU HAVE A
CONDITION THAT AFFECTS PART OF YOUR BRAIN CALLED THE
“basal ganglia”
s SUFFER FROM 0ARKINSONS DISEASE (UNTINGTONS #HOREA
OR A RELATED MOVEMENT DISORDER
s SUFFER FROM UNCORRECTED HYPOKALAEMIA LOW LEVELS OF
POTASSIUM IN THE BODY
s HAVE SEVERE HEART PROBLEMS EG RECENT HEART ATTACK
HEART FAILURE IRREGULAR HEART BEAT FOR WHICH YOU NEED
TO TAKE MEDICINE
s HAVE A FAMILY HISTORY OF UNEXPLAINED FAINTING
BLACKOUTS OR HEART ATTACKS
s ARE TAKING CERTAIN OTHER MEDICINES WHICH CAN AFFECT THE
HEART SEE @4AKING OTHER MEDICINES
s HAVE A RARE HEREDITARY PROBLEM OF GALACTOSE
INTOLERANCE THE ,APP LACTOSE DEFICIENCY OR
GLUCOSE GALACTOSE MALABSORPTION
s ARE LESS AWARE OF THINGS AROUND YOU OR YOUR REACTIONS
become slower.
3ERENACE SHOULD NOT BE GIVEN TO PATIENTS IF THEY ARE IN A
coma.
Warnings and precautions
Take special care with Serenace
Talk to your doctor before you start to take this medicine
if you:
s ARE ELDERLY AS YOU MAY BE MORE SENSITIVE TO THE EFFECTS
of Serenace
s ARE AT RISK OF BLOOD CLOT IN THE VEIN DEEP VEIN
THROMBOSIS
s HAVE OR SOMEONE ELSE IN YOUR FAMILY HAS A HISTORY OF
BLOOD CLOTS AS MEDICINES LIKE THESE HAVE BEEN
associated with formation of blood clots
s SUFFER FROM EPILEPSY OR CONDITIONS THAT MIGHT CAUSE
EPILEPSY SUCH AS ALCOHOL WITHDRAWAL OR BRAIN DAMAGE
s HAVE DISEASED ARTERIES
s SUFFER FROM DEMENTIA
s SUFFER FROM DEPRESSION
s HAVE LOW BLOOD PRESSURE CALCIUM OR MAGNESIUM
LEVELS OR HAVE NOT EATEN FOR A PROLONGED LENGTH OF TIME
s HAVE PROBLEMS WITH ALCOHOL ABUSE OR ALCOHOLISM
s HAVE EVER HAD ANY PROBLEMS WITH YOUR LIVER KIDNEYS
OR HEART OR THERE IS A HISTORY IN YOUR FAMILY OF HEART
problems or sudden death
s HAVE EVER HAD A STROKE TRANSIENT ISCHAEMIC ATTACK
4)! OR HAVE A FAMILY HISTORY OF STROKES
s HAVE EVER HAD A GROWTH IN YOUR ADRENAL GLAND
PHAEOCHROMOCYTOMA OR TROUBLE WITH YOUR THYROID
GLAND WHICH CAUSES TOO MUCH THYROID HORMONE TO BE
MADE THYROTOXICOSIS
s HAVE BEEN FASTING
9OU MAY NEED TO BE MORE CLOSELY MONITORED AND THE
AMOUNT OF 3ERENACE #APSULES YOU TAKE MAY HAVE TO BE
ALTERED )F YOU ARE NOT SURE IF ANY OF THE ABOVE APPLY TO YOU
TALK TO YOUR PHARMACIST BEFORE TAKING 3ERENACE #APSULES
-EDICAL CHECK UPS
9OUR DOCTOR MAY WANT TO TAKE AN ELECTROCARDIOGRAM
%#' BEFORE OR DURING YOUR TREATMENT WITH 3ERENACE
#APSULES4HE %#' MEASURES THE ELECTRICAL ACTIVITY OF
YOUR HEART
Blood tests
9OUR DOCTOR MAY WANT TO CHECK THE LEVELS OF MINERALS
ELECTROLYTES IN YOUR BLOOD

TEVA UK Ref:

REG0064534

WHAT SERENACE IS AND WHAT IT IS USED FOR

Version 3.2

Approved

!VAILABLE SAFETY DATA IN THE PAEDIATRIC POPULATION INDICATE
A RISK OF EXTRAPYRAMIDAL SYMPTOMS INCLUDING TARDIVE
DYSKINESIA INVOLUNTARY REPETITIVE BODY MOVEMENTS
AND SEDATION .O LONG TERM SAFETY DATA AVAILABLE
Taking other medicines
3PECIAL MONITORING MAY BE NEEDED IF YOU ARE TAKING
lithium and Serenace Capsules at the same time. Tell
YOUR DOCTOR STRAIGHT AWAY AND STOP TAKING BOTH
MEDICINES IF YOU GET
s CONFUSED DISORIENTED A HEADACHE BALANCE PROBLEMS
AND FEEL SLEEPY4HESE ARE SIGNS OF SERIOUS CONDITIONS
DO NOT take Serenace if you are taking:
s CERTAIN OTHER MEDICINES WHICH CAN AFFECT THE HEART EG
QUINIDINE BRETYLIUM DISOPYRAMIDE PROCAINAMIDE
AMIODARONE SOTALOL DOFETILIDE
Talk to your doctor if you are taking any of the following:
s ANY OTHER MEDICINE SIMILAR TO 3ERENACE KNOWN AS A
NEUROLEPTIC EG PHENOTHIAZINES SERTINDOLE PIMOZIDE
PROMAZINE AMISULPRIDE
s CERTAIN MEDICINES FOR THE TREATMENT OF DEPRESSION EG
FLUOXETINE AMITRIPTYLINE MAPROTILINE LITHIUM PAROXETINE
s SLEEPING CAPSULES SEDATIVES OR STRONG PAIN KILLERS
s MEDICINES FOR CHANGES IN YOUR HEART BEAT OR ARE TAKING
MEDICINES THAT AFFECT YOUR HEART BEAT
s MEDICINES WHICH CAN AFFECT THE CHEMICALS IN YOUR
BLOODSTREAM KNOWN AS ELECTROLYTES SUCH AS DIURETICS
e.g. furosemide
s CERTAIN ANTIBIOTICS EG MOXIFLOXACIN SPARFLOXACIN
ERYTHROMYCIN
s LEVODOPA FOR 0ARKINSONS DISEASE
s BUSPIRONE FOR ANXIETY
s QUININE AND MEFLOQUINE FOR MALARIA
s INDOMETACIN FOR RHEUMATOID ARTHRITIS
s METHYLDOPA TO LOWER YOUR BLOOD PRESSURE
s CARBAMAZEPINE FOR EPILEPSY
s ANY ANTIHISTAMINE FOR AN ALLERGY OR HAY FEVER
s SYMPATHOMIMETIC AGENTS EG FOUND IN COLD AND FLU
REMEDIES n PLEASE CHECK WITH YOUR PHARMACIST
s ADRENALINE USED IN EMERGENCY SITUATIONS EG TO TREAT
SEVERE ALLERGIC REACTIONS
s MEDICINES FOR THINNING THE BLOOD SUCH AS PHENINDIONE
s MEDICINES FOR A FUNGAL INFECTION SUCH AS KETOCONAZOLE
s LEVOTHYROXINE
0LEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR
HAVE RECENTLY TAKEN ANY OTHER MEDICINES INCLUDING
MEDICINES OBTAINED WITHOUT A PRESCRIPTION )F YOU SUFFER
FROM A DISORDER WITH RELATED MEMORY LOSS YOU SHOULD
TALK FIRST TO YOUR DOCTOR WHO WILL DECIDE IF YOU CAN BE GIVEN
3ERENACE AND WILL EXPLAIN THE POSSIBLE RISKS OF ITS USE
Important information about some of the ingredients of
Serenace
s 0ATIENTS WHO ARE INTOLERANT TO lactose should note that
Serenace capsules contain a small amount of lactose.
)F YOUR DOCTOR HAS TOLD YOU THAT YOU HAVE AN
INTOLERANCE TO SOME SUGARS CONTACT YOUR DOCTOR
BEFORE TAKING THIS MEDICINE
s 4HIS MEDICINE CONTAINS tartrazine (E102) as a colouring
AGENT )T CAN CAUSE ALLERGIC TYPE REACTIONS INCLUDING
ASTHMA )F YOU ARE ALLERGIC TO ASPIRIN YOU ARE MORE
LIKELY TO SUFFER A REACTION
Taking Serenace with food and drink
s $/ ./4 DRINK ALCOHOL WHILST TAKING 3ERENACE
Pregnancy and breast-feeding
s 4HE FOLLOWING SYMPTOMS MAY OCCUR IN NEWBORN
BABIES OF MOTHERS THAT HAVE USED 3ERENACE IN THE LAST
TRIMESTER LAST THREE MONTHS OF THEIR PREGNANCY 
SHAKING MUSCLE STIFFNESS ANDOR WEAKNESS SLEEPINESS
AGITATION BREATHING PROBLEMS AND DIFFICULTY IN
FEEDING )F YOUR BABY DEVELOPS ANY OF THESE SYMPTOMS
YOU MAY NEED TO CONTACT YOUR DOCTOR
s $/ ./4 TAKE 3ERENACE IF YOU ARE BREAST FEEDING4HIS
IS BECAUSE SMALL AMOUNTS MAY PASS INTO MOTHERS MILK
s )F YOU ARE PREGNANT OR PLANNING TO BECOME PREGNANT
ASK YOUR DOCTOR FOR ADVICE BEFORE TAKING THIS MEDICINE
Driving and using machines
s 3ERENACE MAY CAUSE DROWSINESS OR IMPAIRED
ALERTNESS ESPECIALLY AT THE START OF TREATMENT )F YOU
ARE AFFECTED $/ ./4 DRIVE OR OPERATE MACHINERY
WITHOUT DISCUSSING THIS WITH YOUR DOCTOR FIRST

3

HOW TO TAKE SERENACE

!LWAYS TAKE 3ERENACE EXACTLY AS YOUR DOCTOR HAS TOLD
YOU9OU SHOULD CHECK WITH YOUR DOCTOR OR PHARMACIST IF
YOU ARE NOT SURE
9OU MAY NOT FEEL BETTER FOR SEVERAL WEEKS AFTER YOU START
TO TAKE YOUR CAPSULES
4HE CAPSULES SHOULD BE SWALLOWED WHOLE PREFERABLY
WITH A DRINK OF WATER
)F YOU ARE TAKING HIGH DOSES OF 3ERENACE YOUR DOCTOR WILL
GIVE YOU A HIGHER STRENGTH PRODUCT SO THAT YOU DO NOT
NEED TO TAKE A LARGE NUMBER OF CAPSULES EACH DAY4HE
usual dose is:
Adults
s Psychotic and behavioural conditions:
4HE USUAL STARTING DOSE IS BETWEEN  MG  CAPSULES
AND  MG  CAPSULES A DAY TAKEN EITHER AS A SINGLE
dose or two smaller doses.
9OUR DOCTOR MAY INCREASE THIS DOSE UP TO A MAXIMUM
OF  MG A DAY  CAPSULES IN SOME CASES
7HEN YOUR DOCTOR IS HAPPY THAT YOU ARE RESPONDING TO
YOUR TREATMENT THEY MAY GRADUALLY REDUCE THE DOSE
4HIS COULD BE AS LOW AS  MG  CAPSULES TO  MG 
CAPSULES DAILY
s Tourette's Syndrome:
4HE STARTING DOSE IS USUALLY  MG  CAPSULES A DAY
9OUR DOCTOR MAY INCREASE THIS DOSE TO BETWEEN
 MG  CAPSULES AND  MG  CAPSULES A DAY IN
some cases.
7HEN YOUR SYMPTOMS ARE CONTROLLED YOUR DOCTOR WILL
GRADUALLY REDUCE YOUR DOSE TO AROUND  MG
 CAPSULES A DAY

Page 1 of 3

s Nausea and vomiting:
4HE USUAL DOSE IS  MG  CAPSULES A DAY
s Anxiety:
4HE USUAL DOSE IS  MICROGRAMS  CAPSULE TWICE A
DAY
The Elderly
)F YOU ARE ELDERLY YOUR DOCTOR WILL PROBABLY GIVE YOU HALF
THE DOSES MENTIONED ABOVE
Children
9OUR DOCTOR WILL WORK OUT THE DOSE DEPENDING ON YOUR
CHILDS WEIGHT4HE USUAL DOSE IS  TO  MICROGRAMS FOR
EACH KILOGRAM KG OF BODY WEIGHT UP TO A MAXIMUM OF
 MG4EENAGERS MAY BE GIVEN UP TO  MG A DAY
If you take more Serenace than you should
)F YOU OR SOMEONE ELSE SWALLOW A LOT OF THE CAPSULES ALL
TOGETHER OR IF YOU THINK A CHILD HAS SWALLOWED ANY OF THE
CAPSULES CONTACT YOUR NEAREST HOSPITAL CASUALTY
DEPARTMENT OR YOUR DOCTOR IMMEDIATELY
!N OVERDOSE IS LIKELY TO CAUSE MUSCLE WEAKNESS MUSCLE
STIFFNESS SHAKING LOW BLOOD PRESSURE DROWSINESS
0LEASE TAKE THIS LEAFLET ANY REMAINING CAPSULES AND THE
CONTAINER WITH YOU TO THE HOSPITAL OR DOCTOR SO THAT THEY
KNOW WHICH CAPSULES WERE CONSUMED
If you forget to take Serenace Capsules
)F YOU FORGET TO TAKE A CAPSULE TAKE ONE AS SOON AS YOU
REMEMBER UNLESS IT IS NEARLY TIME TO TAKE THE NEXT ONE
$/ ./4 TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN
DOSE )F IT IS NEARLY TIME TO TAKE THE NEXT DOSE WAIT UNTIL
THEN AND THEN CARRY ON AS BEFORE
If you stop taking Serenace
$/ ./4 STOP TAKING 3ERENACE WITHOUT TALKING TO YOUR
DOCTOR FIRST EVEN IF YOU FEEL BETTER
7HEN YOU STOP TAKING 3ERENACE YOUR DOCTOR WILL REDUCE
THE DOSE GRADUALLY TO AVOID THE POSSIBILITY OF WITHDRAWAL
SYMPTOMS SUCH AS FEELING AND BEING SICK AND BEING
UNABLE TO SLEEP OR THE RECURRENCE OF YOUR ORIGINAL
condition.
)F YOU HAVE ANY FURTHER QUESTIONS ON THE USE OF THIS
PRODUCT ASK YOUR DOCTOR OR PHARMACIST

Version:

2

25 March 2014

s RASH
s UNABLE TO PASS URINE
s WEIGHT CHANGES INCREASE OR DECREASE
s DIZZINESS OR SLEEPINESS
Uncommon (affecting less than one person in 100 but
more than one person in 1,000):
s A FALL IN THE NUMBER OF WHITE BLOOD CELLS WHICH CAN
CAUSE FREQUENT INFECTIONS
s CONFUSIONAL STATE
s EPILEPTIC FITS OR SEIZURES CONVULSION
s BLURRED VISION
s RAPID HEART BEAT
s SHORTNESS OF BREATH
s INFLAMMATION OF THE LIVER JAUNDICE YOUR SKIN AND THE
WHITES OF YOUR EYES MAY BECOME YELLOW OR DUE TO A
CHANGE IN THE WAY YOUR LIVER WORKS
s ITCHING SWEATING MORE THAN USUAL
s IF YOU ARE A WOMAN YOU MAY UNEXPECTEDLY PRODUCE
MILK HAVING PAINFUL BREAST AND YOUR PERIODS MAY
BECOME INFREQUENT OR STOP
s SHUFFLING UNBALANCED WALK NECK TILTED TO ONE SIDE
s FEELING TOO WARM HYPERTHERMIA
s FLUID MAY BUILD UP IN YOUR BODY CAUSING SWOLLEN FEET
OR ANKLES
Rare (affecting less than one person in 1000 but more
than one person in 10,000):
s IF YOU ARE A WOMAN YOUR BODY MAY MAKE TOO MUCH OF
the hormone prolactin
s GETTING EXCITED SYMPTOMS OF PSYCHOSIS SUCH AS
ABNORMAL THOUGHTS OR VISION OR HEARING ABNORMAL
sounds
s DIFFICULTY BREATHING OR WHEEZING
s DIFFICULTIES OPENING THE MOUTH 4RISMUS
s MUSCLE TWITCHING
s ABNORMAL HEAVY AND PROLONGED MENSTRUAL PERIODS AT
REGULAR INTERVALS
s ABNORMAL HEART RHYTHMS
Other side effects
s BLOOD ABNORMALITIES WHICH CAN CAUSE FEVER OR CHILLS
SORE THROATS AND ULCERS IN YOUR MOUTH AND THROAT
s FEELING UNWELL CONFUSED OR WEAK FEELING SICK NAUSEA
POSSIBLE SIDE EFFECTS
LOSS OF APPETITE FEELING IRRITABLE4HIS COULD BE AN
ILLNESS CALLED @SYNDROME OF INAPPROPRIATE ANTI DIURETIC
,IKE ALL MEDICINES 3ERENACE CAN CAUSE SIDE EFFECTS
HORMONE SECRETION 3)!$( 
ALTHOUGH NOT EVERYBODY GETS THEM
s LOW LEVEL OF BLOOD GLUCOSE HYPOGLYCAEMIA
Stop taking the capsules and tell your doctor
s DROWSINESS
immediately OR GO TO THE CASUALTY DEPARTMENT AT YOUR
s VERTIGO A SENSATION THAT THE WORLD IS SPINNING AROUND
nearest hospital if the following happens:
YOU
s AN ALLERGIC REACTION CAUSING SWELLING OF THE LIPS FACE
s HEART PROBLEMS CAUSING SYMPTOMS SUCH AS
OR NECK LEADING TO SEVERE DIFFICULTY IN BREATHING
PALPITATIONS ABNORMAL HEART RHYTHMS FAINTING
SEVERE SKIN RASH OR HIVES
BLACKOUTS OR RARELY HEART ATTACKS
4HIS IS A VERY SERIOUS BUT RARE SIDE EFFECT9OU MAY NEED
s SWELLING OF THE VOICE BOX OR CONTRACTION OF THE MUSCLE
urgent medical attention or hospitalisation.
IN THE VOICE BOX
See your doctor immediately IF YOU SUFFER FROM ANY OF THE s LOSS OF APPETITE
FOLLOWING AS YOUR TREATMENT WILL NEED TO BE REVIEWED
s INDIGESTION
s UNCONTROLLED MOVEMENTS ESPECIALLY IN YOUR LIMBS AND s ACUTE LIVER FAILURE
FACE MOUTH AND JAW TREMORS TICS AND MUSCLE SPASM s INFLAMMATION OF BLOOD VESSELS
IN YOUR SHOULDERS NECK BODY AND ARMS4HESE ARE
s FLAKING OR PEELING OF THE SKIN
VERY COMMON SIDE EFFECTS (OWEVER RARELY THIS CAN BE s INFLAMED SKIN RED HOT TO THE TOUCH AND TENDER
SEVERE ENOUGH TO CAUSE BREATHING DIFFICULTIES4HE FIRST s SUDDEN UNEXPLAINED DEATH HAS OCCURRED IN RARE CASES
SIGNS MAY BE UNCONTROLLED MOVEMENTS OF YOUR TONGUE
BUT IT IS NOT KNOWN IF THIS WAS DUE TO THE MEDICINE
s YOUR MUSCLES BEGIN TO FEEL RIGID BODY ADOPTS RIGID
s SWELLING OF FACE
POSTURE OR A MASK LIKE FACE4HESE ARE COMMON SIDE
s FEELING TOO COLD
effects.
If you are concerned about any of these side effects, or if
s EXTREME RESTLESSNESS LOSS OF NORMAL MUSCLE CONTROL
you notice any side effects not listed in this leaflet,
DIFFICULTY IN MOVING SHAKINESS AND LOSS OF MOVEMENT
please tell your doctor or pharmacist.
s YOU FEEL FEVERISH AND BECOME LESS ALERT THAN USUAL OR
YOU FEEL HOT YOU START SWEATING AND YOUR HEARTBEAT
HOW TO STORE SERENACE
speeds up
s BLOOD CLOTS IN THE VEINS ESPECIALLY IN THE LEGS
Keep out of the reach and sight of children.
SYMPTOMS INCLUDE SWELLING PAIN AND REDNESS IN THE
3TORE THE CAPSULES IN A DRY PLACE BELOW ª# +EEP THEM
LEG WHICH MAY TRAVEL THROUGH BLOOD VESSELS TO THE
IN THE ORIGINAL PACKAGE DO NOT PUT THEM INTO ANOTHER
LUNGS CAUSING CHEST PAIN AND DIFFICULTY IN BREATHING
container.
s IN ELDERLY PEOPLE WITH DEMENTIA A SMALL INCREASE IN
$O NOT USE 3ERENACE AFTER THE EXPIRY DATE THAT IS STATED
the number of deaths has been reported for patients
ON THE OUTER PACKAGING4HE EXPIRY DATE REFERS TO THE LAST
TAKING ANTIPSYCHOTICS COMPARED WITH THOSE NOT
DAY OF THAT MONTH
RECEIVING ANTIPSYCHOTICS
-EDICINES SHOULD NOT BE DISPOSED OF VIA WASTEWATER OR
s A SERIOUS PROBLEM CALLED hNEUROLEPTIC MALIGNANT
HOUSEHOLD WASTE !SK YOUR PHARMACIST HOW TO DISPOSE OF
SYNDROMEv 4HE SIGNS MAY INCLUDE
MEDICINES NO LONGER REQUIRED4HESE MEASURES WILL HELP
s &AST HEART BEAT CHANGING BLOOD PRESSURE AND
TO PROTECT THE ENVIRONMENT
SWEATING FOLLOWED BY FEVER
s &ASTER BREATHING MUSCLE STIFFNESS REDUCED
FURTHER INFORMATION
consciousness and coma
s 2AISED LEVELS OF A PROTEIN IN YOUR BLOOD AN ENZYME
What Serenace Capsules contain:
CALLED CREATINE PHOSPHOKINASE
s 4HE ACTIVE INGREDIENT IS HALOPERIDOL  MICROGRAMS
s AN UNCONTROLLED MUSCULAR CONTRACTION SPASM OF THE
s 4HE OTHER INGREDIENTS ARE LACTOSE AND CORN STARCH4HE
LARYNGEAL CORDS ASSOCIATED WITH PURPLE COLORATION OF
CAPSULE SHELL CONTAINS4ITANIUM $IOXIDE %
THE SKIN TONGUE TIE DIFFICULTY IN BREATHING AND TO THE
4ARTRAZINE % AND 0ATENT "LUE 6 % 4HE
PSYCHOLOGICAL EXPERIENCE ASSOCIATED WITH SUCH
PRINTING INK CONTAINS SHELLAC BLACK IRON OXIDE %
DIFFICULTY DEFICIENT SUPPLY OF OXYGEN TO THE BODY
AND PROPYLENE GLYCOL % 
)F YOU NOTICE ANY OF THESE SYMPTOMS SEEK MEDICAL ADVICE
What Serenace Capsules look like and contents of the
IMMEDIATELY
pack:
9OU MAY ALSO EXPERIENCE DIFFICULTIES WITH SEX SUCH AS
s 3ERENACE #APSULES ARE HARD GELATIN CAPSULES4WO TONE
ERECTILE DYSFUNCTION INABILITY TO DEVELOP OR MAINTAIN AN
GREEN PRINTED @.ORTON  ON ONE HALF AND 3%2%.!#%
ERECTION OF THE PENIS DECREASED SEXUAL DESIRE AND
on the other.
SOME MEN MAY EXPERIENCE SWELLING OF THE BREASTS OR
s 4HE CAPSULES ARE AVAILABLE IN PACKS OF     
painful and prolonged erection.
          AND 
4HE FOLLOWING SIDE EFFECTS HAVE BEEN REPORTED AT THE
s .OT ALL PACK SIZES MAY BE MARKETED
APPROXIMATE FREQUENCIES SHOWN
Marketing Authorisation Holder and Manufacturer
Very common (affecting more than one person in 10):
4HE COMPANY RESPONSIBLE FOR MANUFACTURE IS 0IRAMAL
s FEELING AGITATED OR HAVING DIFFICULTY SLEEPING
(EALTHCARE 5+ ,IMITED 7HALTON 2D -ORPETH
s HEADACHE
.ORTHUMBERLAND .% 9!
Common (affecting less than one person in 10 but more 4HE -ARKETING !UTHORISATION HOLDER IS
than one person in 100):
4%6! 5+ ,IMITED %ASTBOURNE ". !'
s DEPRESSION MENTAL PROBLEMS
This leaflet was last revised: 03/2014
s ROLLING OF THE EYES
0, 
s PROBLEMS WITH SIGHT
s A FALL IN BLOOD PRESSURE ON STANDING UP WHICH CAUSES
DIZZINESS LIGHT HEADEDNESS OR FAINTING
s CONSTIPATION DRY MOUTH EXCESSIVE MOUTH WATERING
FEELING SICK BEING SICK
 &
s ABNORMAL LIVER FUNCTION WHICH MAY BE DETECTED BY
X
BLOOD TESTS
XXXXXXX

231-30-01046-F LEA SERENACE (HALOPERIDOL) 500mcg CAP TUK
4

TEVA UK Ref:

5

REG0064534

6

Version 3.2

Approved

Page 2 of 3

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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